BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCITE F DSC

    MDR report key: 3873734 · Received September 24, 2013

    Report

    Report Number
    9612352-2013-00008
    Event Type
    Malfunction
    Date Received
    September 24, 2013
    Date of Event
    September 4, 2013
    Report Date
    September 20, 2013
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    KLE
    PMA / PMN Number
    K093744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) WITH BATCH R59595 WERE SUPPLIED TO CUSTOMERS WORLDWIDE. THERE IS NO RISK TO PATIENT HEALTH. EXCITE F DSC IS A DUAL CURING ADHESIVE AND THEREFORE USUALLY USED IN CLINICAL SITUATIONS WHERE THE RESTORATION IS SOMEWHAT OPAQUE. IN THESE CASES A POSSIBLE BLUE DISCOLORATION IS NOT VISIBLE AND DOES NOT AFFECT THE AESTHETICS OF THE RESTORATION. THIS ALSO APPLIES IN THE ENDODONTIC INDICATION. A BLUE DISCOLORATION CAN BE NOTICEABLE IN TRANSLUCENT RESTORATIONS (E.G. VENEERS) IN THE FRONT OF THE MOUTH. HOWEVER EVEN HERE THE AESTHETICS ARE ONLY AFFECTED WHEN THE CERAMIC IS VERY THIN. AN ADDITIONAL QUALITY CONTROL MONITORING HAS BEEN INTRODUCED SO THAT EVERY BATCH IS CHECKED USING UV/VISUAL ANALYSIS. THE POSSIBILITY OF CHANGING THE MONOMER PRODUCTION PROCESS TO AVOID USING THIS STABILISER IS BEING INVESTIGATED. IT HAS BEEN DECIDED TO UNDERTAKE A FIELD SAFETY CORRECTION ACTION TO REMOVE BATCH R59595 FROM THE MARKET.

    Description of Event or Problem · 1

    THE DENTIST FOUND THAT ONE VENEER ON TOOTH 23 HAD BEEN PLACED. WHEN LIGHT CURING AFTER A FEW SECONDS IT TURNED GREY AND AFTER A BIT MORE CURING IT TURNED BLUE/GREEN (TURQUOISE) AND STAYED BLUE/GREEN AFTER THE LIGHT CURING WAS FINISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483217 EXCITE F DSC AGENT, TOOTH BONDING RESIN PRODUCT CODE: KLE KLE IVOCLAR VIVADENT AG R59595

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention